Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Show all queries
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00154102
Registration number
NCT00154102
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
30/01/2017
Titles & IDs
Public title
Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL)
Query!
Scientific title
Open, Randomized, Controlled, Multicenter Phase III Study Comparing 5FU/ FA Plus Irinotecan Plus Cetuximab Versus 5FU/FA Plus Irinotecan as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Query!
Secondary ID [1]
0
0
EMR 62202-013
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CRYSTAL
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cetuximab
Treatment: Drugs - FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Experimental: Cetuximab Plus FOLFIRI -
Active comparator: FOLFIRI Alone -
Treatment: Drugs: Cetuximab
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Number of Cycles: until progression or unacceptable toxicity develops
Treatment: Drugs: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments
Query!
Assessment method [1]
0
0
Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Query!
Timepoint [1]
0
0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Primary outcome [2]
0
0
Progression-free Survival Time (Chinese V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Wild-Type Population) - Independent Review Committee (IRC) Assessments
Query!
Assessment method [2]
0
0
Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Query!
Timepoint [2]
0
0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Primary outcome [3]
0
0
Progression-free Survival Time (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Query!
Assessment method [3]
0
0
Duration from randomization until radiological progression (based on modified WHO criteria) or death due to any cause.
Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
Query!
Timepoint [3]
0
0
Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [1]
0
0
Overall Survival Time (OS)
Query!
Assessment method [1]
0
0
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Query!
Timepoint [1]
0
0
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Query!
Secondary outcome [2]
0
0
Overall Survival Time (KRAS Wild-Type Population)
Query!
Assessment method [2]
0
0
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Query!
Timepoint [2]
0
0
Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Query!
Secondary outcome [3]
0
0
Overall Survival Time (KRAS Mutant Population)
Query!
Assessment method [3]
0
0
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.
Query!
Timepoint [3]
0
0
Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009
Query!
Secondary outcome [4]
0
0
Best Overall Response Rate - Independent Review Committee (IRC) Assessments
Query!
Assessment method [4]
0
0
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Query!
Timepoint [4]
0
0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [5]
0
0
Best Overall Response Rate (KRAS Wild-Type Population) - Independent Review Committee (IRC) Assessments
Query!
Assessment method [5]
0
0
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Query!
Timepoint [5]
0
0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [6]
0
0
Best Overall Response Rate (KRAS Mutant Population) - Independent Review Committee (IRC) Assessments
Query!
Assessment method [6]
0
0
The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Query!
Timepoint [6]
0
0
evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [7]
0
0
Disease Control Rate - Independent Review Committee (IRC) Assessments
Query!
Assessment method [7]
0
0
The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
Query!
Timepoint [7]
0
0
Evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [8]
0
0
Duration of Response - Independent Review Committee (IRC) Assessments
Query!
Assessment method [8]
0
0
Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).
Patients without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.
Query!
Timepoint [8]
0
0
Time from first assessment of complete response or partial response to disease progression, death or last tumor assessment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [9]
0
0
Participants With No Residual Tumor After Metastatic Surgery
Query!
Assessment method [9]
0
0
Participants with no residual tumor after on-study surgery for metastases
Query!
Timepoint [9]
0
0
time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007
Query!
Secondary outcome [10]
0
0
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Query!
Assessment method [10]
0
0
Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
Query!
Timepoint [10]
0
0
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [11]
0
0
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Query!
Assessment method [11]
0
0
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
Query!
Timepoint [11]
0
0
at baseline, at week 8, at week 16, at week 24, at week 32, and at week 40, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006
Query!
Secondary outcome [12]
0
0
Safety - Number of Patients Experiencing Any Adverse Event
Query!
Assessment method [12]
0
0
Please refer to Adverse Events section for further details
Query!
Timepoint [12]
0
0
time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007
Query!
Eligibility
Key inclusion criteria
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Inoperable metastatic disease
* Immunohistochemical evidence of epidermal growth factor receptor expression in tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Previous irinotecan-based chemotherapy
* Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated more than 6 months before the start of study treatment
* Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of study treatment
* Brain metastasis
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1221
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Bedford Park
Query!
Recruitment hospital [2]
0
0
Research Site - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Research Site - Heidelberg
Query!
Recruitment hospital [4]
0
0
Research Site - Nedlands
Query!
Recruitment hospital [5]
0
0
Research Site - West Perth
Query!
Recruitment hospital [6]
0
0
Research Site - Woodville
Query!
Recruitment postcode(s) [1]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
- Nedlands
Query!
Recruitment postcode(s) [5]
0
0
- West Perth
Query!
Recruitment postcode(s) [6]
0
0
- Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Innsbruck
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Klagenfurt
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Kufstein
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Salzburg
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
St. Pölten
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
St. Veit an der Glan
Query!
Country [8]
0
0
Austria
Query!
State/province [8]
0
0
Wels
Query!
Country [9]
0
0
Austria
Query!
State/province [9]
0
0
Wien
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Antwerpen
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Bonheiden
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Bruxelles
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Edegem
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Gent
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Leuven
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Liège
Query!
Country [17]
0
0
Brazil
Query!
State/province [17]
0
0
Goiania
Query!
Country [18]
0
0
Brazil
Query!
State/province [18]
0
0
Porto Alegre
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Santo André
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Sao Paulo
Query!
Country [21]
0
0
Bulgaria
Query!
State/province [21]
0
0
Pleven
Query!
Country [22]
0
0
Bulgaria
Query!
State/province [22]
0
0
Plovidiv
Query!
Country [23]
0
0
Bulgaria
Query!
State/province [23]
0
0
Sofia
Query!
Country [24]
0
0
Bulgaria
Query!
State/province [24]
0
0
Varna
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Santiago-Las Condes
Query!
Country [26]
0
0
Chile
Query!
State/province [26]
0
0
Santiago-Providencia
Query!
Country [27]
0
0
Czech Republic
Query!
State/province [27]
0
0
Chomutov
Query!
Country [28]
0
0
Czech Republic
Query!
State/province [28]
0
0
Prague
Query!
Country [29]
0
0
Finland
Query!
State/province [29]
0
0
Turku
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Bordeaux
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Boulogne-Billancourt
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Colmar
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Grenoble
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
La Roche sur Yon
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Lorient
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Marseille
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Nantes
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Perigueux
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Rennes Cedex
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Saint Gregoire
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Strasbourg
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Toulon
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Villejuif Cedex
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Dortmund
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Dresden
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Düsseldorf
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Essen
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Frankfurt am Main
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Freiburg
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Göttingen
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Halle
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Hamburg
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Heidelberg
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Homburg/Saar
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Jena
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Mainz
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Mannheim
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
München
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Oldenburg
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Ulm
Query!
Country [61]
0
0
Greece
Query!
State/province [61]
0
0
Alexandroupolis
Query!
Country [62]
0
0
Greece
Query!
State/province [62]
0
0
Athens
Query!
Country [63]
0
0
Greece
Query!
State/province [63]
0
0
Heraklion
Query!
Country [64]
0
0
Hong Kong
Query!
State/province [64]
0
0
Pokfulam
Query!
Country [65]
0
0
Hong Kong
Query!
State/province [65]
0
0
Shatin
Query!
Country [66]
0
0
Hungary
Query!
State/province [66]
0
0
Budapest
Query!
Country [67]
0
0
Hungary
Query!
State/province [67]
0
0
Debrecen
Query!
Country [68]
0
0
Hungary
Query!
State/province [68]
0
0
Györ
Query!
Country [69]
0
0
Hungary
Query!
State/province [69]
0
0
Kecskemét
Query!
Country [70]
0
0
Hungary
Query!
State/province [70]
0
0
Pécs
Query!
Country [71]
0
0
Italy
Query!
State/province [71]
0
0
Ancona
Query!
Country [72]
0
0
Italy
Query!
State/province [72]
0
0
Aviano
Query!
Country [73]
0
0
Italy
Query!
State/province [73]
0
0
Bari
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Benevento
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Firenze
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Mantova
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Milano
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Modena
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Napoli
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Reggio Emilia
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Roma
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Rozzano
Query!
Country [83]
0
0
Korea, Republic of
Query!
State/province [83]
0
0
Seoul
Query!
Country [84]
0
0
Mexico
Query!
State/province [84]
0
0
Mexico
Query!
Country [85]
0
0
Netherlands
Query!
State/province [85]
0
0
Amsterdam
Query!
Country [86]
0
0
Netherlands
Query!
State/province [86]
0
0
Apeldoom
Query!
Country [87]
0
0
Netherlands
Query!
State/province [87]
0
0
Blaricum
Query!
Country [88]
0
0
Netherlands
Query!
State/province [88]
0
0
Den Haag
Query!
Country [89]
0
0
Netherlands
Query!
State/province [89]
0
0
Roosendaal
Query!
Country [90]
0
0
Netherlands
Query!
State/province [90]
0
0
Zwolle
Query!
Country [91]
0
0
Poland
Query!
State/province [91]
0
0
Bialystok
Query!
Country [92]
0
0
Poland
Query!
State/province [92]
0
0
Gliwice
Query!
Country [93]
0
0
Poland
Query!
State/province [93]
0
0
Krakow
Query!
Country [94]
0
0
Poland
Query!
State/province [94]
0
0
Opole
Query!
Country [95]
0
0
Poland
Query!
State/province [95]
0
0
Poznan
Query!
Country [96]
0
0
Poland
Query!
State/province [96]
0
0
Warsaw
Query!
Country [97]
0
0
Poland
Query!
State/province [97]
0
0
Wroclaw
Query!
Country [98]
0
0
Romania
Query!
State/province [98]
0
0
Cluj Napoca
Query!
Country [99]
0
0
Romania
Query!
State/province [99]
0
0
Iasi
Query!
Country [100]
0
0
Romania
Query!
State/province [100]
0
0
Suceava
Query!
Country [101]
0
0
Russian Federation
Query!
State/province [101]
0
0
Moscow
Query!
Country [102]
0
0
Russian Federation
Query!
State/province [102]
0
0
Saint Petersburg
Query!
Country [103]
0
0
Russian Federation
Query!
State/province [103]
0
0
Yaroslavl
Query!
Country [104]
0
0
Singapore
Query!
State/province [104]
0
0
Singapore
Query!
Country [105]
0
0
Slovakia
Query!
State/province [105]
0
0
Banska Bystrica
Query!
Country [106]
0
0
Slovakia
Query!
State/province [106]
0
0
Bratislava
Query!
Country [107]
0
0
Slovakia
Query!
State/province [107]
0
0
Kosice
Query!
Country [108]
0
0
Slovakia
Query!
State/province [108]
0
0
Trnava
Query!
Country [109]
0
0
Slovakia
Query!
State/province [109]
0
0
Zilina
Query!
Country [110]
0
0
South Africa
Query!
State/province [110]
0
0
Cape Town
Query!
Country [111]
0
0
South Africa
Query!
State/province [111]
0
0
Durban
Query!
Country [112]
0
0
South Africa
Query!
State/province [112]
0
0
Johannesburg
Query!
Country [113]
0
0
South Africa
Query!
State/province [113]
0
0
Port Elizabeth
Query!
Country [114]
0
0
South Africa
Query!
State/province [114]
0
0
Pretoria
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
A Coruna
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Barcelona
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Cadiz
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Madrid
Query!
Country [119]
0
0
Spain
Query!
State/province [119]
0
0
Palma de Mallorca
Query!
Country [120]
0
0
Spain
Query!
State/province [120]
0
0
Valencia
Query!
Country [121]
0
0
Sweden
Query!
State/province [121]
0
0
Göteborg
Query!
Country [122]
0
0
Sweden
Query!
State/province [122]
0
0
Stockholm
Query!
Country [123]
0
0
Taiwan
Query!
State/province [123]
0
0
Changhua
Query!
Country [124]
0
0
Taiwan
Query!
State/province [124]
0
0
Chiayi
Query!
Country [125]
0
0
Taiwan
Query!
State/province [125]
0
0
Taipei
Query!
Country [126]
0
0
Taiwan
Query!
State/province [126]
0
0
Taoyuan
Query!
Country [127]
0
0
Turkey
Query!
State/province [127]
0
0
Ankara
Query!
Country [128]
0
0
Turkey
Query!
State/province [128]
0
0
Istanbul
Query!
Country [129]
0
0
Turkey
Query!
State/province [129]
0
0
Izmir
Query!
Country [130]
0
0
Ukraine
Query!
State/province [130]
0
0
Charkassy
Query!
Country [131]
0
0
Ukraine
Query!
State/province [131]
0
0
Donetsk
Query!
Country [132]
0
0
Ukraine
Query!
State/province [132]
0
0
Ivano-Frankivsk
Query!
Country [133]
0
0
Ukraine
Query!
State/province [133]
0
0
Kiev
Query!
Country [134]
0
0
Ukraine
Query!
State/province [134]
0
0
Krivoy Rog
Query!
Country [135]
0
0
Ukraine
Query!
State/province [135]
0
0
Lugansk
Query!
Country [136]
0
0
Ukraine
Query!
State/province [136]
0
0
Lviv
Query!
Country [137]
0
0
Ukraine
Query!
State/province [137]
0
0
Uzhgorod
Query!
Country [138]
0
0
Ukraine
Query!
State/province [138]
0
0
Zhaporozhye
Query!
Country [139]
0
0
United Kingdom
Query!
State/province [139]
0
0
Brighton
Query!
Country [140]
0
0
United Kingdom
Query!
State/province [140]
0
0
Cambridge
Query!
Country [141]
0
0
United Kingdom
Query!
State/province [141]
0
0
Glasgow
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
Guildford
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Kent
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Leicester
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
London
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
Peterborough
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
Rhyl
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Sutton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck KGaA, Darmstadt, Germany
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor. Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data. After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator. The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00154102
Query!
Trial related presentations / publications
Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019. Van Cutsem E, Lang I, Folprecht G, Nowacki M, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Celik I, Kohne C Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer (mCRC): The influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO 2010 Gastrointestinal Cancers Symposium, Orlando, USA January 2010 Abstract No: 281 Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Zubel A, Van Cutsem E Cetuximab plus FOLFIRI in 1st-line treatment of metastatic colorectal cancer: Quality of life (QoL) analysis of patients (pts) with KRAS wild-type (wt) tumours in the CRYSTAL trial. European Journal of Cancer Supplements. 2009 7(2):345 Dercle L, Lu L, Lichtenstein P, Yang H, Wang D, Zhu J, Wu F, Piessevaux H, Schwartz LH, Zhao B. Impact of Variability in Portal Venous Phase Acquisition Timing in Tumor Density Measurement and Treatment Response Assessment: Metastatic Colorectal Cancer as a Paradigm. JCO Clin Cancer Inform. 2017 Nov;1:1-8. doi: 10.1200/CCI.17.00108. Tejpar S, Stintzing S, Ciardiello F, Tabernero J, Van Cutsem E, Beier F, Esser R, Lenz HJ, Heinemann V. Prognostic and Predictive Relevance of Primary Tumor Location in Patients With RAS Wild-Type Metastatic Colorectal Cancer: Retrospective Analyses of the CRYSTAL and FIRE-3 Trials. JAMA Oncol. 2017 Feb 1;3(2):194-201. doi: 10.1001/jamaoncol.2016.3797. Erratum In: JAMA Oncol. 2017 Dec 1;3(12):1742. doi: 10.1001/jamaoncol.2017.4136. Licitra L, Storkel S, Kerr KM, Van Cutsem E, Pirker R, Hirsch FR, Vermorken JB, von Heydebreck A, Esser R, Celik I, Ciardiello F. Predictive value of epidermal growth factor receptor expression for first-line chemotherapy plus cetuximab in patients with head and neck and colorectal cancer: analysis of data from the EXTREME and CRYSTAL studies. Eur J Cancer. 2013 Apr;49(6):1161-8. doi: 10.1016/j.ejca.2012.11.018. Epub 2012 Dec 19.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Eric van Cutsem, Professor
Query!
Address
0
0
University Hospital Gasthuisberg, Department Internal Medicine, Leuven, Belgium
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang ...
[
More Details
]
Journal
Van Cutsem E, Lang I, Folprecht G, Nowacki M, Casc...
[
More Details
]
Journal
Lang I, Kohne CH, Folprecht G, Nowacki MP, Cascinu...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00154102
Download to PDF
Show all queries